- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01861275
Ischaemic Stroke and Sleep Apnea in Northern Part of Finland
May 23, 2016 updated by: University of Oulu
Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study
Obstructive sleep apnoea is a risk factor for ischaemic stroke.
study hypothesis: In prospective study the investigators want to know how many ischaemic stroke patients have sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.
Study Overview
Detailed Description
In prospective study the investigators include all over 18 years old patients who came to emergency room for ischaemic stroke.
Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have ischaemic stroke and no thrombolysis and 100 study patients who will have thrombolysis.
The investigators do sleep registration during hospital staying within 2 days after patients have felt ill.Follow-up registration will be done after 6 months at home.
Study Type
Observational
Enrollment (Actual)
256
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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northern Finland
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Oulu, northern Finland, Finland, 90029
- Oulu university hospital,department of neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
residents of Oulu university hospital area.
consecutive patient sampling
Description
Inclusion Criteria:
- over 18 years old patients that have cerebral palsy and are able to participate to the study.
Exclusion Criteria:
- no co-operation and need for intensive care unit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nasal CPAP
We want to study the nasal-cpap treatment and it's compliance in sleep apnea patients with ischaemic stroke.
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Nasal CPAP treatment for obstructive sleep apnoea
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no Nasal CPAP
No nasal-cpap in sleep apnea patients with ischaemic stroke.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cerebral palsy events and severity of osa
Time Frame: from six months to twenty four months
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in prospective study outcome measure is severity of osa in 6months follow-up
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from six months to twenty four months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tarja Saaresranta, Md PhD, University hospital of Turku
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huhtakangas JK, Saaresranta T, Vahanikkila H, Huhtakangas J. Nocturnal hypoxemia and central apneas increase mortality, but not recurrent ischemic events after ischemic stroke. Sleep Med. 2022 Sep;97:1-9. doi: 10.1016/j.sleep.2022.05.014. Epub 2022 May 23.
- Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Unattended sleep study in screening for sleep apnea in the acute phase of ischemic stroke. Sleep Med. 2020 Jan;65:121-126. doi: 10.1016/j.sleep.2019.08.002. Epub 2019 Aug 8.
- Huhtakangas JK, Saaresranta T, Bloigu R, Huhtakangas J. The Evolution of Sleep Apnea Six Months After Acute Ischemic Stroke and Thrombolysis. J Clin Sleep Med. 2018 Dec 15;14(12):2005-2011. doi: 10.5664/jcsm.7524. Erratum In: J Clin Sleep Med. 2020 May 15;16(5):837-838.
- Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Prevalence of sleep apnea at the acute phase of ischemic stroke with or without thrombolysis. Sleep Med. 2017 Dec;40:40-46. doi: 10.1016/j.sleep.2017.08.018. Epub 2017 Oct 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
May 22, 2013
First Posted (Estimate)
May 23, 2013
Study Record Updates
Last Update Posted (Estimate)
May 24, 2016
Last Update Submitted That Met QC Criteria
May 23, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Brain Damage, Chronic
- Signs and Symptoms, Respiratory
- Stroke
- Sleep Apnea Syndromes
- Cerebral Palsy
- Ischemic Stroke
- Apnea
Other Study ID Numbers
- 36/2013 (Other Identifier: Oulu university hospital)
- 36/2013 UO (Other Identifier: Oulu university hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Write a paper.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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